Selectively Bendable Remote Gripping Tool

ABSTRACT

A hand-held gripping device that allows a surgeon to reach interior portions of a person&#39;s anatomy, includes a gripping portion having a pair of jaws and/or nets movable relative to each other between fully clamped and fully opened positions thereof, a handle portion spaced apart from the jaw portion by a bendable central portion that is hollow and corrugated, with a cord extending therethrough.

RELATED APPLICATIONS

This application is a continuation-in-part application of U.S. patentapplication Ser. No. 14/822,238, filed on Aug. 10, 2015, which is acontinuation-in-part application of U.S. patent application Ser. No.14/684,000, filed on Apr. 10, 2015, which is a continuation-in-partapplication of Ser. No. 14/539,021, filed on Nov. 12, 2014, which is acontinuation-in-part of U.S. patent application Ser. No. 14/535,539,filed on Nov. 7, 2014 (now issued U.S. Pat. No. 9,095,127, issued Aug.4, 2015), which is a continuation-in-part of U.S. patent applicationSer. No. 14/290,207, filed on May 29, 2014 (now issued U.S. Pat. No.8,985,659, issued Mar. 24, 2015, which is a continuation-in-part of U.S.patent application Ser. No. 14/163,521 filed on Jan. 24, 2014 (now U.S.Pat. No. 8,833,817, issued Sep. 16, 2014), which is acontinuation-in-part application of U.S. patent application Ser. No.14/078,830 filed on Nov. 13, 2013 (now U.S. Pat. No. 8,807,615, issuedAug. 19, 2014), which is a continuation-in-part of U.S. patentapplication Ser. No. 13/771,813 filed on Feb. 20, 2013 (now U.S. Pat.No. 8,585,114, issued Nov. 19, 2013), and claims priority from U.S.Provisional Patent Application Ser. No. 61/601,789, filed on Feb. 22,2012. This application also seeks priority from U.S. patent applicationSer. No. 29/558,227, filed Mar. 16, 2016, which is a continuation ofU.S. patent application Ser. No. 29/462,798, filed Aug. 8, 2013(abandoned). This application is also a continuation-in-part ofPCT/US2013/054275 having an international filing date of Aug. 9, 2013and a priority date of Feb. 20, 2013. The entire disclosure of the priorapplications are considered to be part of the disclosure of theaccompanying application and are hereby incorporated by reference.

FIELD OF THE INVENTION

The present invention is directed to a selectively bendable remoteaccess gripping tool that includes a jaw portion having a pair of jawsor nets movable relative to each other between clamped and openedpositions thereof, a handle portion spaced apart from the jaw portion bya bendable central portion that has a hollow, corrugated member that isbendable, a cord extending through the central portion of the hollowbendable member that connects the jaw portion and the handle portion.

BACKGROUND OF THE INVENTION

In the fields of surgery, dentistry and orthodontia, professionals oftenhave a desire to reach interior portions of a person's anatomy to graspobjects, tissue, etc. Many prior art devices to achieve such objectivesare linear with grasping jaws, while still others have a flexibleportion that facilitates some angular adjustments. Such tools, however,are often complicated in terms of construction, often employing railsand jointed connections that rotate relative to each other to facilitatedesired flexibility of the tool along at least an extent thereof. Asimpler, cost effective, and versatile tool is therefore desired thatcan facilitate such professional's procedures involving reaching intointerior portions of a person's anatomy to grasp objects, tissue, etc.

Occluded blood vessels can be caused by a blood clot (i.e. thrombus)that forms in the blood vessel or by a blood clot that travelsdownstream (i.e. embolus). The blockage disrupts blood flow, whichprevents oxygen and nutrients from being delivered to their intendedlocations. Tissue distal of a blood clot that is deprived of oxygen andnutrients can no longer function properly. For every minute thattreatment is delayed, additional cellular death of critical tissue canoccur.

Current technology for blood flow restoration, for example for treatingcerebral arteries occluded by thrombi, can often take hours toreestablish flow in the artery, and can lead to unintendedcomplications. Apparatuses and methods for treating cerebral thrombi areoften ineffective or only partially effective at resolving thrombusremoval, and may result in distal embolization or embolization ofuninvolved arteries. For example, some current devices are designed topierce through a thrombus, or are designed to deploy completely distalof the thrombus before engaging the thrombus. These devices can oftenfail to capture all of a thrombus, can damage vessel walls distal of athrombus, can be difficult to maneuver, can unintentionally dislodgeportions of a thrombus prior to capture, and/or can take significantamounts of time to restore blood flow. Acute stroke is one of theleading causes of death worldwide; an estimated 85% of acute strokes arecaused by cerebral ischemia. About 30% to 40% are large-vesselocclusions amenable to intervention.

A stroke is caused by a rupture or an occlusion of a blood vessel whichleads to oxygen deprivation in the brain. In the United States, nearlyeight hundred thousand people suffer a stroke each year, and over onehundred and forty thousand people die from strokes each year. Stroke isthe leading cause of serious, long-term disability in the United Statesand the third leading cause of death. Approximately three-quarters ofstrokes in the United States are first attacks and approximatelyone-quarter are recurrent attacks. Eighty seven percent are ischemic innature, meaning that they are caused by a restriction, obstruction, orblockage in the blood supply of the patient, and thirteen percent arehemorrhagic, meaning that they are caused by excessive bleeding. Theeconomic cost of stroke to the United States is over forty billiondollars per year. The direct costs of medical care and therapy arealmost thirty billion dollars per year.

It is well known in the art that the extent to which treatment of astroke is successful in preventing death and/or in reducing theconsequent damage to a patient is largely influenced by the time whichelapses between the onset of the stroke and the proper treatment of thestroke. The elapsed time is a function of not only whether or not apatient is able to get to a medical facility or hospital, but also thenature of the stroke and whether or not the particular medical facilityor hospital to which the patient is initially brought is best equippedto treat the stroke. The capability of the medical facility to treat theparticular stroke may not be known until the patient is properlyevaluated and analyzed.

Blood clots or emboli to the pulmonary arteries of the lung, the brain,the peripheral arteries of the extremities, in the venous system, or indialysis access vessels are potentially life and/or limb threateningconditions. Delivered systemically, thrombolytic drugs typically requireseveral hours to days to accomplish dissolving these clots. In caseswhere time is of the essence, such as cases where an arterialthromboembolism is causing severe tissue ischemia (e.g., an evolvingstroke or an evolving myocardial infarction) the time which may berequired for the thrombolytic drugs to fully lyse or dissolve the bloodclot and restore arterial blood flow may be too long to avoid orminimize the impending infarction. Thrombolytic drugs also have anapproximately 5% incidence of major complications such as hemorrhage andstroke. Conventional devices are often difficult to advance into curvedand tortuous vessels such as the pulmonary arteries. While devicesavailable in the marketplace may break up a clot and suction theresulting particles out, they often infuse large volumes of fluid aspart of their action, which may be physiologically difficult to handlefor the patient.

There is a great need for improved devices, device systems, and methodsfor increasing blood flow through a blood vessel as described herein.None of the existing medical mechanical thrombectomy devices address allnecessary needs to date. The high prevalence and high rates of death anddisability caused by ischemic stroke call for the urgent need for moreeffective and accessible therapeutic alternatives to the population atrisk.

There is therefore a need for devices that can rapidly and safely beused during intravascular interventions to prevent distal embolizationby capture of blood clots or atheromatous material.

Transluminal, catheter-based interventional procedures are highlyoperator-skill-dependent, and can be difficult or impossible to performin small or tortuous blood vessels. None of the transluminallydeployable clot capturing type of catheters are perfectly designed toaddress ischemic strokes because, while they are typically capable ofremoving an offending blood clot without the need for suction orapplication of energy (e.g., laser, ultrasound) which could be injuriousto the delicate, small blood vessels of the brain, they are a) notequipped with appropriate guidewire passage lumens to allow them to bepassed over previously inserted, small-diameter (e.g., 0.006-0.018 inch)guidewires, b) they are not adapted for rapid exchange over a guidewireof standard length (e.g., a guidewire which is less than twice thelength of the catheter) and c) the clot capturing receptacles of thesecatheters are not optimally constructed and configured for removal ofclots from very small blood vessels as are typically found in the brain.

Major disadvantages of existing mechanical thrombectomy devices includethat they often can only capture and remove embolus that are firm andcan be held together as one piece and are not capable of capturing smallemboli that break off from a larger embolus, and can lead tocomplications such as blockage of distal smaller vessels, vesseldissection, perforation and hemorrhage arise as a result ofover-manipulation in the vessel.

Moreover, some existing devices may capture an embolus, but then losegrasp of it so that it migrates and deposits it incidentally in anotherarea of the neurovasculature, creating the potential for a new stroke ina different part of the neurovasculature. Existing mechanicalthrombectomy devices are also constructed of two or more distinct piecesthat require either joints or bonding between a delivery system and atreatment device, with this connection presenting occasions ofunintentional separation of the two pieces, thus leaving the treatmentdevice in the body during embolus retrieval. Also, the treatment portionof conventional mechanical thrombectomy devices tend to be larger thanthe delivery system.

Guide wires stiff enough to penetrate hard occlusions have thedisadvantage that their inflexibility and straight tips make navigatingthrough tortuous vessels difficult and increase the risk of vesselperforation.

Conventional therapies to treat stroke include thrombolytic therapy andcatheter directed thrombectomy (CDT). Drawbacks of thrombolytic therapyinclude hemorrhagic risk. Conventional CDT systems often employ anintroducer sheath or catheter to the target site, with such largerintroducer sheaths increasing the risk of trauma to the patient, andbeing harder to navigate through the vessels.

Conventional catheter devices use a shaft comprising an outer tubeconnected to the sheath and an inner shaft such that the proximalmovement of the sheath is accomplished by imposing an endwise tension onthe outer tube, with the inner shaft carrying an endwise compressionstress. Such a catheter effectively has telescoping inner and outertubes, with a deployable wire nest being radially constrained by theouter tube. Retraction of the outer tube removes the constraint on theclot removal device and permits it to expand to its deployedconfiguration. One disadvantage is that in use, such devices require themedical practitioner to maintain the device in an unchanged axialdisposition relative to the site in the body of the patient, whilepulling back on the outer tube of the shaft to release the expandableportion of the device. This pulling back of the outer tube requiresrelative movement of the outer tube in the bodily lumen (or guidecatheter) in which it has been advanced to the site of the thrombus. Anyfriction or resistance to axial movement of the outer tube in the lumenin which it is located hinders the objective of maintaining the devicein a precise disposition.

One conventional device is the Merci retrieval device made by ConcentricMedical, and another is sold by Penumbra, Inc., which employs suction topull out a clot. Both of these devices are often unsuccessful in theirintended functions. Recent reports indicate that the Trevo and Solatairedevices, also of similar operation in terms of employing outer and innerluminal movements, are superior in various respects to the Merci andPenumbra devices. All of these devices, however, rely upon a dual lumentranslational construction to achieve employment of a thrombus capturedevice. The present invention addresses this issue by providing adistinctly different and better way to achieve the objective of safely,promptly and effectively capturing a thrombus and reducing its volumewhile being conveyed out of the body.

Existing common concerns of physicians who practice angioplasty include:concern that the thrombectomy device may capture an embolus, only tolose hold of it and accidentally deposit it in another area of theneurovasculature; concern that the device may not be able to capture a‘break-off’ piece of the embolus, which may migrate further into theneurovasculature; concern that the relatively large device may preventit from accessing and treating clots in small-diameter vessels; andconcern that the devices usually require adhesive joining or bondingbetween the delivery system and the treatment device. In the lattercase, in some instances a concern is that the adhesive bonding may fail,presenting the possibility that the pieces may separate, presenting aserious complication in the procedure. These concerns are addressed bythe present invention as the pair of netting structures ensures securecapturing of a thrombus without the threat that there would be any breakoff pieces of the emboli. The small profile provided by the presentembodiments of the present invention provides for a way to access evennarrow, convoluted blood vessels and to capture an emboli in astraightforward netting operation with the operation of a hapticfriendly trigger operation of a handle by a surgeon.

A large number of medical procedures require the use of a medical deviceto remove an obstruction from a body lumen, vessel, or other organ. Aninherent risk in such procedures is that mobilizing or otherwisedisturbing the obstruction can potentially create further harm if theobstruction or a fragment thereof dislodges from the retrieval device.If a particle or the obstruction breaks free from the device and flowsdownstream, it is highly likely that the particle or obstruction willbecome trapped in smaller and more tortuous anatomy. In many cases, thephysician will no longer be able to use the same retrieval device toagain remove the obstruction because the size of the device may preventadvancing the device to the site of the new obstruction. Such concernsare addressed by the present invention as the netting structure ofpreferred embodiments captures the entire thrombus and thus avoids thethreats associated with breaking up of the thrombus as is a commonconcern with conventional devices.

A variety of mechanisms have been employed to steer conventionalcatheters, with some specialized catheter systems having dozens of pullwires being articulated by a dedicated motor attached to the proximalend. Alternative articulation systems utilize electrically actuatedshape memory alloy structures, piezoelectric actuation, phase changeactuation, and the like. These steerable systems increase the complexityand price of devices and have questionable benefits in practice. Asarticulation systems for catheters get more complex, it can be more andmore challenging to maintain accurate control over these flexiblebodies. For example, pull wires that pass through bent flexiblecatheters often slide around the bends over surfaces within thecatheter, with the sliding interaction extending around not only bendsintentionally commanded by the user, but also around bends that areimposed by the tissues surrounding the catheter. The result is thatexisting devices are deficient in various respects, hampering theability of a surgeon to promptly advance a tool through a blood vesselto the site of a thrombus, and to then effectively capture the entirethrombus/emboli in a manner that does not pose a risk that pieces of thethrombus/emboli will dislodge and potentially cause other problems.Existing devices further do not permit the thrombus to be reduced insidea secure capturing confine so that damage to the vessels is avoided whenattempting to remove the thrombus from the blood vessels.

In still other procedures that do not involve a thrombus in braintissue, for example, the treatment of deep vein thrombosis (DVT), whichresults from a clot that forms in one of the large veins of the legleading to venous hypertension and inflammation, a need exists for abetter system and method to remove occlusions. Venous thrombosis canoccur in healthy as well as sick individuals. A complication mostcommonly associated with venous thrombosis is the condition known as“pulmonary embolism.” A pulmonary embolus is actually a clot that hasbroken free from a vein wall and has traveled to the pulmonary artery,and then, if not removed, to a lung. When an embolus blocks a bloodvessel in the lung, breathing is compromised and death may ensue.Accordingly, early treatment of DVT is desirable.

The longer the occlusion remains, the more risk of damaging the valvesof the vein that normally stop blood from flowing backwards. Aconfluence of symptoms comprised of chronic pain, swelling, skinulcerations and pain can develop that can markedly reduce the quality oflife. A rapid, direct method to remove clots in the leg, with minimallytic drugs, is needed to treat DVT patients. Such a device and methodis provided by the present invention.

Over the last 10 years there has been major technological breakthroughfor the mechanical thrombectomy devices, starting with MERCI® retrieverand reaching stent retriever devices (e.g. SOLITAIRE® and TREVO®). Ascompared to such devices, however, the present invention provides adevice and related method to provide a more flexible profile, allowingeasier navigation and faster access to vascular occlusion site. Theimportance of agility in the endovascular treatment in order to preventirreversible damage to a person's brain is immense and the provision ofa device that is simple, easily employed and that can be used wellwithin the 3-hour time period after a stroke to save the person's lifeand brain is a central focus of the present invention.

SUMMARY OF THE INVENTION

Recent developments in medical technology and associated treatments havebeen focused on clearing or removing thromboembolisms or “blood clots”from the cervical and cerebral vasculature in order to treatthromboembolic stroke victims. Thromboembolic stroke is a lifethreatening condition that consists of arrested blood flow to a regionof the brain due to a thromboembolisum blocking a blood vessel feedingthat region. Such thrombi often originate in the left heart chambers,break free into the aorta and flow downstream into the cervical neckarteries e.g. carotid arteries, and then ultimately lodge into anarrowed vessel somewhere down the narrowing vascular tree of thecerebral arteries associated with the brain in the head. Once lodged,the thrombus occludes flow along the vessel downstream of the blockage,thus arresting blood flow to the downstream blood vessel and causing thestroke.

Occlusion of a blood vessel can be caused by a thrombus (i.e., bloodclot) that forms in a blood vessel, or by an embolus, i.e., a blood clotthat travels downstream. The blockage disrupts blood flow, whichprevents oxygen and nutrients from being delivered to their intendedlocations. Tissue distal to a blood clot that is deprived of oxygen andnutrients can no longer function properly. For every minute thattreatment is delayed, additional cellular death of critical tissue canoccur. As used herein a “vessel” or “lumen” refers to blood vessels(including arteries and veins) and other suitable body organs having alumen, such as the gastrointestinal tract (e.g., esophagus, stomach,small intestine, colon, rectum), bile ducts, urinary bladder, ureter,urethra, trachea, bronchi, and the like. Pulmonary embolisms occur inthe pulmonary arteries. Typically, access to such pulmonary embolisms isachieved using an introducer device that is inserted into a patient intotheir femoral vein in the pelvic area of the patient. The tools anddevices needed to treat the pulmonary embolism are then inserted throughthe introducer into the femoral vein through the inferior vena cava tothe patient's heart. Other access locations into the venous circulatorysystem of a patient are possible, for example, the user can gain accessthrough the jugular vein, the subclavian vein, the brachial vein or anyother vein that connects or eventually leads to the superior vena cava.Use of other vessels that are closer to right atrium of the patient'sheart are attractive because it reduces the length of the instrumentsneeded to reach the pulmonary embolism.

Current technology for blood flow restoration, for example for treatingcerebral arteries occluded by thrombi, can often take hours toreestablish flow in the artery, and can lead to unintendedcomplications. Apparatus and methods for treating cerebral thrombi areoften ineffective or only partially effective at resolving thrombusremoval, and may result in distal embolization or embolization ofuninvolved arteries. For example, some current devices are designed topierce through a thrombus, or are designed to deploy distally to thethrombus before engaging the thrombus. These devices often fail tocapture all of a thrombus, can damage vessel walls distal of a thrombus,can be difficult to maneuver, can unintentionally dislodge portions of athrombus prior to capture, and/or can take significant amounts of timeto restore blood flow. Dislodgment of portions of the thrombus, referredto as secondary emboli, often cause complications because the secondaryemboli may travel downstream and occlude other vessels or arteries.

Various embodiments of the present invention are directed to “basket”retrieval surgical devices that have a net assembly, such as a pair ofnets, at a distal end able to surround a captured stone, thrombus orcalculi during retrieval. Unlike prior art devices, which while havingbasket-type devices, collapse into the distal end of a catheter duringinsertion, and are then extended from the end of the catheter whendeployed, preferred embodiments of the present invention do not requireretraction of the net assemblies into a catheter. Some types of theseinstruments employ a retrieval collapsible basket arranged within aflexible catheter formed as a tubular sheath with the basket and thesheath moving relative to each other to open and close the basket. Thebasket can retract inside the sheath or protract from the catheter toopen the basket to form a cage to thus allow entrance of the object intothe basket. Retraction of the basket into the sheath results in the cagecollapsing and entrapping the object in the basket. Other types ofretrieval devices employ miniaturized grasping legs that are unattachedat a distal end of the grabber and joined at a proximal base of thegrabber. The legs are movable relative to the sheath to achieve acontracted position within the sheath and an extended position outsideof the sheath in the form of an open grasper. The distal ends of thelegs are farther apart from each other when the grabber is in the openposition than when in the closed position. The grasping legs aretypically formed of elastic wires with insufficient rigidity to reliablyhold retrieved objects and thus, the legs may deform and drop theobjects during operation.

Other traditional devices employ a single loop snare that requiresskilled manipulation to capture a desired object. In an attempt toprovide a snare with improved cross sectional vessel coverage, multiloop snares have been developed. These snares include loops which arejoined only at their proximal ends to a manipulation shaft, andotherwise are not joined at any point between the shaft and the distalends of the loops. Such loops often become displaced and/or entangled,thus preventing the snare from opening during operation

Moreover, unlike prior art basket-type retrieval devices, whichtypically require a physician to advance the device past a stone mass,followed by deployment of the retrieval device, and subsequent pullingback of the basket toward the stone to capture the stone, variouspreferred embodiments of the present invention provide the ability tosecure stone masses without having to move the device past a stone.

Additionally, prior art basket retrieval devices often become stuck orwedged during stone removal, resulting in damage to surrounding tissueor tissue lining caused by a physician forcing the basket and stonethrough an area in which the stone has become stuck or wedged. To avoidsuch damage, it may be necessary to release the stone and break it intosmaller fragments. Unfortunately, typical basket retrieval devices donot allow the physician to release easily the stone and continuebreaking it up before removal is again attempted. Similar situationsarise using prior art surgical “graspers” instead of a basket device.Typical graspers employ three or four prongs that are manipulated tocapture a stone from the front side of the stone, by grasping it. When astone becomes stuck or wedged during removal, such graspers are able torelease the stone. Unfortunately, typical graspers often do not hold onto stones as well as baskets. Moreover, it can be difficult to capture astone using a grasper, and once captured, it is easy for the stone to bereleased inadvertently. Thus, in the past, over the course of aprocedure, a physician often needs to use both graspers and basket-typedevices to manipulate a stone, break up the stone, and remove fragmentsof the stone. Using current graspers and baskets, a physician may needto switch devices during the procedure. Switching devices typicallyrequires withdrawal of one device and insertion of another. In contrast,certain embodiments of the present invention employ cutting jaws thatcan be employed once the pair of nets captures the thrombi so as toreduce the size of the mass and make it easier to remove form the body.

Certain embodiments of the surgical device include an assembly having aplurality of spring-like finger members, which may be composed ofnitinol, stainless steel, a Co—Cr alloy, or a titanium alloy, thoughother materials also may be used. In various aspects of the presentinvention, a surgical retrieval device is inserted into a body tractwhile the multi-fingered retrieval assembly is in a closed position asthe retrieval device is placed in a vessel and then maneuvered tocapture material. Once the material is captured, the retrieval device,along with the material, are withdrawn from the body. In variousembodiments, netting material can be associated with the plurality offingers so as to achieve the advantages of both grasper and thebasket-type devices. Thus, a surgical retrieval device may be adapted tohave a distal end (preferably replaceable) that permits the device to beused as a grasper for grasping material similar to forceps. In othersituations, the distal end can be a multi-fingered retrieval netassembly so that the device may be used as a basket-type retrievaldevice to capture material within a basket formed by the nettingstretched between the fingers of the multi-finger retrieval assembly. Inpreferred embodiments, the distal portion of the preferred surgicalretrieval device of the present invention is designed to capture notonly the thrombus, but also any secondary emboli, and therefore, preventsecondary emboli from traveling downstream during clot retrieval.

There has been a long felt an unmet need to provide a surgical devicethat is adept at removing harder material, such as calcium (e.g. harderthan thrombus and plaque). Cutting and removal of such harder materialshas generally required additional procedure time and increased risks.The present invention provides such a device as it can capture thethrombus and then employ sharp cutting implements to reduce the size ofthe same without risk that pieces of the thrombus would escape. It isalso important to have a device that is easy to use by a physician andis compatible with present therapeutic devices and methods. Embodimentsof the present disclosure contemplate various mechanical cuttingfeatures provided in combination with the jaws that are compatible withexisting protocols.

The present device can reduce the invasiveness and potential traumapreviously associated with various medical procedures. The removal of acalculus, such as, for example, a kidney stone, a ureteral stone, aurethral stone, a urinary bladder stone, or a stone in the biliary treesuch as a gallbladder stone or a bile duct stone and the like from thebody, is one area where the present invention may be used with success.The present device permits the removal of stones and other material fromthe body without the need for major surgery. Generally, the device isguided through the body to the site of the stone and is used tograsp/net and/or cut up and remove the stone, preferably under theguidance of an endoscope.

One problem with known baskets is that it often is difficult to removethe basket containing the material from the body without damaging thesurrounding tissue and it is not possible to release the capturedmaterial from the basket. In some instances, a stone is of such a sizethat it is incapable of being removed while it is captured within thebasket. In other instances, the body duct or orifice, such as the ureteror ureteral orifice junction (where the ureter and bladder join), is toosmall to allow for passage of the basket with the captured stone. If anexcessive force is used to attempt to remove the basket and the capturedmaterial, tissue may be damaged. Sometimes surgery is required todislodge both the basket and the captured material. This problem issolved by use of the present invention as its cutting implements can beemployed after the stone is captured by the grasping portion/nets, sothat its size is reduced so it can be removed without further harmingthe patient.

Various embodiments of the present invention provide a surgicalextractor which is capable of capturing and releasing foreign orbiological material (e.g. stones, calculi, etc.), and preferably reducethe size of the captured material so as to make its passage out of thebody less harmful to the patient. In accordance with various embodimentsof the present invention, a surgical retrieval device, and relatedmethods, use a basket/pair of nets formed by a plurality of legs toretrieve foreign or biological material.

Thus, the selectively bendable remote grasping device of the presentinvention finds various uses and application in endoscopic surgery.Endoscopic instruments are often preferred over traditional opensurgical devices since the use of a natural orifice tends to reduce thepost-operative recovery time and complications. Thus, precise placementof a working end of a tool at a desired surgical site through a naturalorifice is achievable by use of the present invention, which can engageand/or treat tissue in a number of ways to achieve a diagnostic ortherapeutic effect. Prior art devices generally rely upon a movingsheath arrangement where movement of grasping devices at a distal endare controlled through the shaft via longitudinal translations, whichcan interfere with the flexibility of the shaft. Traditional devicesalso typically require a significant amount of force necessary toarticulate and/or actuate the working end and some surgeons cannothandle such force repeatedly or well. While use of electrical motorshave been attempted, surgeons typically prefer to experience feedbackfrom the working end to assure proper operation of the end effector. Incontrast to the user-feedback effects that are not suitably realizablein motor-driven devices, the present device provides for a superiorhaptic feel by a surgeon so that he/she can manipulate the working endof the device to achieve extraction of a stone, thrombus, etc.

Various embodiments of the present invention are directed to the removalof an intravascular or intracavitary thrombus or other material whichmay frequently require removal to restore blood flow or other normalfunctionality of an organ system affected.

Various embodiments employ a procedure that involves access to thefemoral artery in a patient's leg or the radial artery in the arm, toadvance a guidewire/device through the vascular system to the occludedsite.

In certain embodiments, the device is guided to intended places in thepatient's body by applying magnetic attraction, including for example,existing large magnetic fields using coils outside the patient's body todirect the device distal end inside the heart or brain or other bodypart of a patient. Thus, the employment of a magnet on the grasping endof the device facilitates such magnetic guidance to a point where athrombus or stone may be located, thus assisting the travels throughconvoluted blood vessels, etc.

Access guidewires are known medical devices used in the vasculature orother anatomical passageway to act as a guide for other devices, e.g., acatheter. Typically, the guidewire is inserted into an artery or veinand guided through the vasculature under fluoroscopy (real time x-rayimaging) to the location of interest. While guidewires can be used incombination with the present device, oftentimes this is unnecessarygiven the ability of the device to be pushed through vessels and thenactivated to grasp objects therein. The corrugated design of the presentinvention permits such a pushing of the central column in a manner thatpermits requisite flexibility to address sharp turns of vascularpassages.

Thus while some have stated that advancing a flexible guidewire and/orcatheter through a tortuously branched network of body lumens might becompared to “pushing a rope,” in preferred embodiments of the presentinvention, the articulated corrugated construction of the presentinvention permits a surgeon to advance the tool as described hereinthrough convoluted blood vessels to reach an occluding thrombus. Inpreferred embodiments, due to the single aperture in the center of thepreferred articulated loc-line-like individual but joined piecescreating a single channel, with a pulling member (cord) passing throughthe central aperture of the stacked pieces and that connects the distalend with the thrombus capturing end to the handle and trigger end of thedevice, a surgeon is provided with a device that can traverse the sharpturns of blood vessels. The ability to effectively push the connectedarticulated pieces so that the pair of nets advance to the position ofthe thrombus is rendered possible, including when a guidewire (andpreferably one that is a fiber optic construction) is first advancedthrough the blood vessel to the thrombus. In some embodiments, thecorrugated device of the present invention is then associated with theguidewire so that the device can be pushed along with the guidewire(e.g. through the central column) to the thrombus. When the pair of netsis pushed along the guidewire to the point of the thrombus, the nets canthen be positioned so that they surround the thrombus and then thetrigger can be operated to clamp the nets around the thrombus andencompass most if not all of the thrombus. Once the thrombus isentrapped by the pair of nets it can be withdrawn from the blood vesselby pulling it out along with or subsequent to the guidewire beingremoved. In certain embodiments, the provision of cutting implementspermits the thrombus to be reduced in size while inside the enclosednets. This provides for a way to reduce the volume and size of thethrombus so as to permit easier passage of the thrombus through theconvoluted return path through the vasculature.

Still other embodiments employ an encapsulated amount of tPA or anotherclot dissolving compound such that after the thrombus is captured withinthe netting assembly as described herein, the fracturing of suchencapsulated structure will release the contents of the encapsulatedstructure so that the captured thrombus can be dissolved, thus reducingits volume or structure such that it is easier to move the thrombus inexisting the blood vessels.

In certain preferred embodiments, the central column of the devicecomprises a corrugated segment comprising a plurality of interconnectedconnectors, such as “loc-line” plastic elements. For certain embodimentsthat include the use of particular linked plastic components thatcomprise the flexible portion of the device, incorporated entirely bythis reference are U.S. Pat. No. 6,042,155 to Lockwood; U.S. Pat. No.5,778,939 to Hok-Yin; U.S. Pat. No. 5,667,146 to Pimental et al.; andU.S. Pat. No. 7,533,906 to Luettgen.

Another aspect of the present invention is directed to effectivelysealing the material inside a bag after collection. While methodsemploying adhesives is preferred, others can also be used, such as withties, twisting of the bag, spinning the bag after it is filled withmaterial, etc.

Given the flexible nature of the device, it is possible to twist twoseparate extensions around each other, thus forming a single extensionthat comprises a twisted (helical) portion of a device, which can havetwo separate triggers to operate the pulling of cords extending in theseparate extended, twisted portions. This facilitates further optionsfor a user in certain situations where an additional set of operabledistal features, such as a separate set of jaws, may be useful.

A further object of the present invention is to provide a light sourceassociated with the central portion section in connection with elongategripper tools. A lighting source can also be positioned at the distalend of the device so that a user can more readily see the distal end andfacilitate proper positioning of the distal end to perform operations,such as clamping of jaws around a distant object that may be in adarkened environment. LED lighting sources with small, battery poweredenergy sources are preferred, but one of skill in the art willappreciate, given the guidance provided herein, the vast variety ofother lighting arrangements and features that can be employed whilestill being within the scope of the claimed invention. A magnifyingviewing device (e.g., a distally positioned camera) can also be providedto assist the user in viewing the distal end of the device in particularapplications, such as when a detailed and sensitive manipulation of aremote object is required and the user requires magnification of thedistal end to properly position the device to perform desired functions.

Various embodiments of the present invention are directed to the removalof intravascular or intracavitary thrombus or other material which mayfrequently require removal to restore blood flow or other normalfunctionality of an organ system affected. Various embodiments employ aprocedure that involves access to the femoral artery in a patient's legor the radial artery in the arm, to advance a guidewire/device throughthe vascular system to the occluded site.

Capturing thrombus material in an enclosure such that it can be removedfrom the body, without the additional risk that there will be break-awaypieces that could present other obstructions, is one advantage ofseveral of the embodiments of the present invention.

In yet other embodiments, given the flexible nature of the device, it ispossible to twist two separate extensions around each other, thusforming a single extension that comprises a twisted (helical) portion ofa device, which can have two separate triggers to operate the pulling ofcords extending in the separate extended, twisted portions. Thisfacilitates further options for a user in certain situations where anadditional set of operable distal features, such as a separate set ofjaws, may be useful.

A further object of the present invention is to provide a light sourceassociated with the central portion section in connection with elongategripper tools and the netting structures associated with thethrombectomy catheter devices described herein. A lighting source canalso be positioned at the distal end of the device so that a user canmore readily see the distal end and facilitate proper positioning of thedistal end to perform operations, such as clamping of jaws around adistant object that may be in a darkened environment. LED lightingsources with small, battery powered energy sources are preferred, butone of skill in the art will appreciate, given the guidance providedherein, the vast variety of other lighting arrangements and featuresthat can be employed while still being within the scope of the claimedinvention, including fiber opti fibers, including those employed as aguidewire for the articulated device as described herein. A magnifyingviewing device (e.g., a distally or proximatally positioned camera) canalso be provided to assist the user in viewing the distal end of thedevice in particular applications, such as when a detailed and sensitivemanipulation of a remote object is required and the user requiresmagnification of the distal end to properly position the device toperform desired functions.

Conventional therapies to treat stroke include thrombolytic therapy andcatheter directed thrombectomy (CDT). Drawbacks of thrombolytic therapyinclude hemorrhagic risk. Conventional CDT systems often employ anintroducer sheath or catheter to the target site, with such largerintroducer sheaths increasing the risk of trauma to the patient, andbeing harder to navigate through the vessels. Conventional catheterdevices use a shaft comprising an outer tube connected to the sheath andan inner shaft such that the proximal movement of the sheath isaccomplished by imposing an endwise tension on the outer tube, with theinner shaft carrying an endwise compression stress, e.g. see WO2003/003944, WO 2003/002020, and WO 2004/062458. One disadvantage isthat in use, such devices require the medical practitioner to maintainthe device in an unchanged axial disposition relative to the site in thebody of the patient, while pulling back on the outer tube of the shaftto release the expandable portion of the device. This pulling back ofthe outer tube requires relative movement of the outer tube in thebodily lumen (or guide catheter) in which it has been advanced to thesite of the thrombus. Any friction or resistance to axial movement ofthe outer tube in the lumen in which it is located hinders the objectiveof maintaining the device in a precise disposition.

BRIEF DESCRIPTION OF THE DRAWINGS

Other advantages of the present invention will be readily appreciated asthe same becomes better understood by reference to the followingdetailed description when considered with the accompanying drawings,wherein:

FIG. 1 illustrates the key emphasis in the treatment of stroke victims:“Time is Brain.”

FIG. 2A is a perspective view of a surgical device having differentlyconfigured grasping structures that are adapted to be reversiblyopened/closed via operation of the handle trigger.

FIG. 2B shows one embodiment where the flexible grasping tool isemployed to access an object in a patient's cerebral artery (not toscale).

FIG. 3 shows a perspective view of a variable length flexible grasperwith a miniature movable jaw assembly and associated bag/net structures.

FIG. 4 shows an embodiment as employed to access a patient's cerebralartery.

FIG. 5 shows an embodiment where opposing nets and cutting jaws areshown to facilitate reduction in the size of a blood clot, stone orforeign object prior to or after grasping the object within the opposingcollapsible nets.

FIG. 6 is a perspective view of another embodiment showing theengagement elements (jaws) and a lighting element.

FIG. 7 shows an embodiment where the flexible grasping tool hasadjustable locking collars along its extent.

FIG. 8 shows a perspective view of a variable length flexible grasperhaving a miniature net assembly at its distal end.

FIG. 9 shows another embodiment illustrating a net assembly with onestructure with a loose net and the opposing structure with a taut net.

WRITTEN DESCRIPTION OF CERTAIN PREFERRED EMBODIMENTS

It will be understood that the disclosed embodiments are merelyexemplary of the invention that may be embodied in various andalternative forms. The figures are not necessarily to scale, somefeatures may be exaggerated or minimized to show details of particularcomponents. Therefore, specific structural and functional detailsdisclosed herein are not to be interpreted as limiting, but merely as arepresentative basis for teaching one skilled in the art to variouslyemploy the present invention. For the following description, theactuatable tool head assembly is described as a gripper having a jawassembly 11. It is understood, however, that any type of actuatable toolhead assembly may be used.

As disclosed in the figures, various embodiments of the presentinvention generally comprise a hand-held gripping device having a jawportion (indicated generally at 10) comprising a pair of jaws 11 a, 11 band a handle portion (indicated generally at 40) spaced apart by aselectively extendible central portion (indicated generally at 70). Thehandle portion 40 comprises a manually-actuatable trigger 41 operativelyconnected to the jaws of the jaw portion by a pull member. Actuation ofthe trigger 41 is operative to move the pull member to therebyselectively position the pair of jaws 11 a, 11 b between fully clampedand fully opened positions thereof It will be understood that the jawconstruction and the handle portion construction is intended asexemplary only, and that those of skill in the art will appreciate howto adapt such portions as desired, consistent with facilitatingoperation of the bendable column gripping device as hereinafterdescribed.

A pull member is interconnected with the jaw and handle portions suchthat manual actuation of the trigger 41 effects movement of the jaws 11a, 11 b. In certain embodiments, the user-actuatable release trigger 41of the present invention comprises a release button 42 disposed on thetrigger 41 of the handle portion 40. In the event that the distancebetween the jaw portion 11 and the handle portion 40 is not appropriatein light of the task contemplated by the user, the user may adjust thelength of the central portion by first unscrewing a collet assembly 80to thus permit telescoping movement of first and second tubular members.The user next actuates the release trigger, either by depressing therelease button or turning the collar (depending on the form of theinvention), which actions cause the second coupling to move from theengaged to the disengaged position. At this point, the pull member maybe lengthened or shortened concurrently with telescoping movement of thefirst and second tubular members. Thus, while depressing the releasetrigger 42, the user grasps the second tubular member and changes thedistance between the handle portion and the gripping portion as desired.After the desired length is obtained, the user releases release triggerand tightens the collet assembly to thereby fix the lengths of each ofthe central portion and the pull member.

Selective positioning of the first and second tubular members may beeffected by rotational movement of one of the first or second tubularmembers of the central portion.

In certain embodiments, the gripping device of this embodiment comprisesa selectively extendible central portion 70 including a first tubularmember 71 slidingly telescopingly received within a second,larger-diameter tubular member 73. In order to fix the relativepositions of the first 71 and second 73 tubular members, there isprovided a collet assembly 80.

A locking mechanism may be provided to fix the pivotal position of thetrigger 41, and thereby fix the relative positions of the jaws 11between the fully open and fully closed positions thereof.

In operation, from the position wherein the jaws 11 are fully opened, auser manually depresses trigger 41 to retract the pull rod/cord 50 andthereby move the jaws 11 toward each other.

To understand and appreciate the varied and numerous applications of thepresent invention in the context of tools that do not employ thegripping jaw device used as an illustrative example herein, theinventors incorporate by reference herein, in their entireties, thefollowing patents to provide the detailed embodiments that, with thefeatures here described, facilitate far easier access to previouslydifficult to reach areas so that the various functional assemblies atthe remote end of a tool can be used effectively: Hsu, U.S. Pat. Nos.6,513,844, 6,520,556, and 6,739,637, 4,669,769 to Polder, Jr; U.S. Pat.No. 4,962,957 to Traber; U.S. Pat. No. 8,061,751 to Hatcher; U.S. Pat.No. 7,934,756 to Kroeze; U.S. Pat. No. 7,665,782 to Buzby et al.; U.S.Pat. No. 8,091,936 to Graziano; U.S. Pat. No. 7,980,609 to Khubani; U.S.Pat. No. 5,895,082 to Kaluzny; U.S. Pat. No. 5,590,923 to Berger et al.;as well as U.S. Pat. No. 4,962,957 to Traber; U.S. Pat. No. 4,709,839;U.S. Pat. No. 3,527,492 to Hollis; U.S. Pat. No. 4,613,179 to van Zelm;U.S. Pat. No. 4,669,769 to Polder; U.S. Pat. No. 6,257,634 to Wei; U.S.Pat. No. 7,004,520 to Khubani; U.S. Pat. No. 6,513,844 to Hsu; U.S. Pat.No. 6,571,479 to Wu; and U.S. Pat. No. 6,848,731 to Khubani; U.S. Pat.No. 4,033,618 to Lamb; U.S. Pat. No. 5,823,592 to Kalidindi; U.S. Pat.No. 4,483,562 to Schoolman; U.S. Pat. No. 5,647,622 to Schectman; U.S.Pat. No. 1,519,938 to Smith; U.S. Pat. No. 2,947,564 to Winther; U.S.Pat. Publication No. 2003/0236549 to Bonadio, et al; U.S. Pat. No.5,776,196 to Griffiths; U.S. Pat. No. 7,934,756 to Kroeze and U.S. Pat.No. 4,253,697 to Acosta.

It will be appreciated from the above disclosure that the presentinvention improves upon the prior art by providing a bendable grippingdevice that is robust yet simple in design, and that allows easyadjustment of the direction of the jaws 11 to reach around tight cornersor other places where a straight columned device would simply notfunction to retrieve desired objects remote from the user.

In one embodiment, a hand held gripping device is provided that has ajaw portion comprising a pair of jaws 11 that are movable relative toeach other between fully clamped and fully open positions. A handleportion 40 is spaced apart from the jaw portion 11 by a selectivelyextendable portion, the handle portion having a manually actuabletrigger connected to the jaw portion. An extendable pole member,preferably running longitudinally through a tubular section, operativelyconnecting the jaw portion 11 to the handle portion 40, is provided.Actuation of the trigger 41 is therefore operative to move the polemember to selectively position the pair of jaws 11 between fully clampedand fully opened positions. Between the jaw portion 11 and the handleportion 40 is therefore a central portion, preferably comprising ahollow, corrugated member 30. Such corrugated member 30 preferably hasalternating ridges and grooves such that the central portion of thedevice is able to bend in order to attain predetermined shapes. Inparticular embodiments, at least one cord is connected between thehandle portion and the jaw portion 11, such that the cord extendsthrough the central portion of the device.

As illustrated in FIG. 2, in certain embodiments of the presentinvention, two or more corrugated members 30 are provided at differentrelative locations along the device, and more specifically along thecentral portion of the device. In preferred embodiments, at least twothirds of the central portion comprise the corrugated member 30. Alocking member 80, preferably a locking collar, may be associated with acentral portion. (FIG. 7). The locking member 80 can alternatively bereferred to as a coupling member. In a preferred embodiment, the lockingmember 80 comprises a selectively radially expandable mandrel.

In other embodiments, a user actuable trigger 41 comprises two operabletriggers with the operation of a first trigger 41 causing the reversalopening and closing of the jaws 11, whereas the other trigger (notshown) causes the distal end of the device to move such that the distalend bends in relationship to the longitudinal axis of the device. Inother embodiments, a selective positioning of a knob (not shown), suchknob position near the trigger/handle portion of the device, is providedin order to cause rotational movement of the distal end of the devicethrough manual adjustment of the knob.

In still other embodiments the majority of the portion between thehandle portion and the jaw portion comprises corrugated material 30. Insuch an embodiment, a locking member 80 can be employed, so as toselectively adjust the length of the device in a telescopingrelationship, even though the telescoping members themselves are made ofa corrugated, bendable material. In other embodiments, however, thelocking member 80 can be dispensed with, and the corrugated member 30can comprise the entirety of the portion between the handle portion 40and the jaw portion 11 of the device. In such embodiments, it ispossible to compress the device in a coiled manner, makingtransportation and storage of such a device far easier.

An objective is to provide a gripping device including a lockingmechanism for locking the gripping jaws, claws, grasping members, 11etc. in a holding or grasping or gripping position. Thus, in certainembodiments a device is provided that includes a handle body, a handgrip 40 secured to the handle body having a trigger 41 connected to acord that extends through a flexible corridor 30, preferably one that iscorrugated, and more preferably constructed of loc-line elements linkedtogether, at least one gripping jaw or claw 11 movable via manipulationof the trigger 41, and a locking mechanism for locking the jaw or claw11 into a closed position. The locking mechanism which may be associatedwith a release trigger 42, may include, for example, a pawl rotatablysecured to a hand grip and having a first end for engaging with thehandle body, the handle body including a plurality of teeth formedtherein with the pawl including teeth for engaging with the teeth of thehandle body. One of skill in the art, however, will appreciate thevaried other locking devices that can supplant the pawl/teeth design oflocking mechanisms that can be employed with the present invention.

In more general embodiments, the present invention is directed to ahand-held reacher for gripping an object and includes a handle portion40, a jaw portion 10, and a shaft extending between the handle portionand the jaw portion, with such extended portion including at least onesection that is flexible 30, preferably corrugated and most preferablyconstructed of loc-line-type articulated joints that have hollowinteriors to facilitate a cord extending through the interior of theflexible corridor formed. At one end of such a device there is at leastone jaw/claw portion 11 having at least one of the jaws 11 movablebetween an open position and a closed position, and the handle portion40 having a manually-operable trigger 41 for moving the jaws 11 betweenthe open and closed position. An additional locking member operable viaa release trigger 42 for releasably locking the jaws in a closed orpartially closed position is also a feature of preferred embodiments.

In still other embodiments, the present invention is directed to ahand-held gripping device having a jaw portion 10 that includes a pairof jaws 11 movable relative to each other between fully clamped andfully opened positions. A handle portion 40 is spaced apart from the jawportion 10 by a selectively extendible central portion, with the handleportion including a first manually-actuatable trigger 41 operativelyconnected to the jaw portion 10 by a selectively extendible pull memberat least substantially disposed within the bendable, preferablycorrugated central portion 30. Actuation of the trigger 41 is operativeto move the pull member to thereby selectively position the pair of jaws11 between the fully clamped and fully opened positions. The centralportion can be constructed of various materials, includingball-and-socket connectable members of varying lengths, diameters, etc,with such members having a hollow, interior through which a cord or wirecan extend through, thus connecting a handle portion 41 to a movable jawportion 10 of a device. Preferably such a corrugated member 30 hasalternating ridges and grooves, which may be covered by an outer sheathof preferably flexible material, such as rubber, fabric or plastic, withthe corrugated member 30 preferably being bendable so as to attain apredetermined shape.

In preferred embodiments, the corrugated member 30 is made of loc-lineconnected elements that have ball and socket connections that permitsubstantial flexibility of a connected length thereof. A pull member,such as at least one cord, is operatively connected to the handleportion 40 at one end and to the jaw portion 10 at another end of thedevice. The cord extends through and is preferably entirely encompassedby the central portion. In one embodiment, the corrugated member 30 hasa first configuration whereby prior to actuation of the actuationtrigger 41, the pair of jaws 11 is in the fully opened position and thecorrugated member is bent. A locking member 80 may be operativelyassociated with the central portion so that two adjacent members of thecentral portion can be moved with respect to each other in a slidinglytelescoping relationship and can then be locked into place. The lockingmember 80 may be a selectively radially expandable mandrel, radiallyexpanded into engagement with the adjacent members to permit the lengthof the pull member to be varied. The corrugated member 30 is preferablyconstructed of plastic and is adapted to be bendable so as to attain apredetermined shape.

In certain embodiments, at least two portions of the central portioncolumn are made of hollow, corrugated members 30 such that a user canpreposition each of the portions for a desired bent configuration. Thecentral portion comprises at least 6 inches of the hollow, corrugatedmember 30 and two or more corrugated members may be provided atdifferent relative locations along the central portion of the device.Preferably, at least two thirds of the central portion comprise thebendable portion that is adapted to be coiled to facilitatetransportation and storage, and further includes a locking memberoperable between a first locking position and a second unlockingposition. The actuatable trigger 41 preferably includes a manuallyoperable release trigger 42. The central portion in certain embodimentsalso includes a bendable portion made of rubber.

In various embodiments, the distal end portions can be substituted withdifferently configured mechanisms, such as the replacement of a gripperjaw end with different tool elements. Thus, in certain embodiments, withone device having the handle 40, trigger 41 and flexible central portion30, one can achieve a myriad of different desired operations simply byremoving and replacing end tools that have complementary detachablehousings associated therewith that interact and reversibly connect tothe non-handle end of the tool. For example, and departing from astrictly movable jaw member embodiment, certain embodiments of thepresent invention are directed to a cupping member that may haveflexible, rubber-like memory features to reversibly encompass material(by the moving jaw features) and be either integrally connected orreversibly connected to the distal end of the device.

FIG. 2A shows an embodiment with spring-like claw scoop membersassociated with an articulated, bendable central portion. Incorporatedherein by this reference are the following to illustrate the variousways such members can be provided with the flexible and bendable centralportion, workable via the trigger handle as described herein: U.S. Pat.No. 7,281,740 to Fields; U.S. Patent Publication No. US/2009/0200812 toMambru; U.S. Pat. No. 4,477,111 to Crooks U.S. Pat. No. 6,106,042 toMcCloy and U.S. Patent Publication No. 2014/0152031 to Ballacchino.

FIG. 3 discloses another embodiment with multiple-claw scoop membershaving a bag/net associated therewith, connected to an articulated,bendable central portion and trigger handle. As mentioned above, theemployment of such spring-like fingers on the operational end of thetool permits the triggered handle to manipulate the materials to begrasped, and provides for a significant variety of weights, materials,constructions, etc. to be employed.

Various net assemblies, ranging in shape, design, materials, dimensions,and orientation with respect to the central column, etc. can beemployed. The hand-held netting tool is preferably adapted to permitreversibly disassociable net attachments such that different types,designs, sizes, mesh patterns, geometries, etc. can be accommodated by auser's selection of desired nets for particular uses. The various waysthe net pairs can be reversibly attached will be readily appreciated bythose skilled in the art, but one preferred way is to fashion the distalend of the device with a fitted connector that can be pulled outward viaa spring attachment associated with the cord extending through thedevice. A mating hook structure may be employed to attach associated netpairs to the bendable tool at such distal end. Different kinds and sizesof net heads may be attached to allow for a wide range of differentconfigurations. Indeed, in some embodiments, only one net is employed onone side, with the other clamping/closure member being a more rigidnet/mesh materials (similar to a tennis racket surface). Thus, in oneembodiment the tool comprises a pair of net assemblies where one of thepair is a rectangular shaped wire structure with a loose net associatedtherewith, and the opposing paired structure is a rectangular shapedwire structure with a taut net associated therewith.

Various embodiments of the present invention relate to a small versionof the device as described herein, such a device finding use in asurgical dental or orthodontic environment and other places andsituations where very small dimensions are required to fit throughspaces, such as lumens, vascular spaces, internal body cavities, etc.Thus, in certain embodiments, the selectively bendable remote grippingtool has relatively small dimensions so it can be easily inserted intothe body through known guiding catheters. Various instruments are knownin the art for removing various objects/foreign articles 50 from thebody, such as instruments used for the removal of objects such as kidneystones, gallstones, blood clots, thrombus clots, occlusions, calcinatedplaques, urinary stones or stones of the bile duct; for removing foreignarticles from the vascular system of a patient or from a body duct ororifice, such as the ureter or ureteral orifice junction, nasalpassages, etc., such foreign articles 50 including vena cava filters,parts of medical devices, such as catheters, guidewires, cardiac leads,etc., which may break and become detached during medical procedures.Most of such instruments employ a flexible catheter formed as a tubularsheath adapted to penetrate body passages to reach the location fromwhere the object is to be evacuated, typically employing flexible wiresto snare or capture targeted objects.

Incorporated herein by this reference in their entireties are thefollowing for details as to the dimensions and materials that may beemployed for certain elements and aspects of the present describedembodiments: U.S. Pat. Nos. 5,658,296; 6,168,603; and U.S. Pat. No.6,491,698 to Bates et al.; U.S. Pat. No. 5,300,086 to Gory et al.; U.S.Pat. No. 5,944,728 to Bates; U.S. Pat. No. 6,331,183 to Suon; and U.S.Pat. No. 6,506,209 to Teruo; U.S. Pat. No. 6,679,893 to Tran; U.S. Pat.No. 8,469,970 to Diamant; 20140276920 to Hendrick; 20140155908 toRosenbluth; 20130317516 to Teague; 20140121672 to Folk; and 20100204711to Kear. In certain embodiments of the present invention the movablejaws are operable via the trigger on the handle end of the device. Insome embodiments, such jaws are preferably constructed to collapse andretract inside an elongated sheath. In the protracted position, the jawsare open so as to grasp the object. The trigger may be operated to graspan object and subsequent removal of the central portion with itscorrugated flexible extent, enables the whole device to be removed fromthe body organ together with the object immobilized within the jaws/net.In certain embodiments, the reversibly movable opposing graspingstructures 11, e.g., jaws, fingers, nets (15, 16), etc. are guidedthrough the body to the site of an object, such as a kidney stone, andis used to grasp and remove the stone, e.g., under the guidance of anendoscope.

Preferably the jaws comprise spring-like fingers 11 with sufficientrigidity to reliably hold a foreign body 50. In other embodiments, thedistal end of the device comprises a pair of nets 15, 16 that aremovable between open and closed positions such that a foreign body canbe entrapped within the nets upon movement of the trigger to move thenets into the closed position. One will appreciate that in certainembodiments, the surgical/dental device described herein is essentiallya mere smaller version of the larger device described herein that isable to grasp larger objects.

As illustrated in FIG. 4, a method that can be performed using thepresent selectively bendable tool is to provide access to a site withinthe interior portions of a person's anatomy, such as in the femoralartery or other vascular or other peripheral vessels, such as a brachialartery. A guide catheter is advanced and the bendable tool of thepresent invention is advanced through an inner lumen of such guidecatheter until the distal end is positioned adjacent to an object, suchas a thromboembolism 50, located in the middle cerebral artery. Thephysician can then operate the trigger on the handle to cause thegrasping assembly so that the jaws 11, net 15, 16 or other graspingelements advance around the thromboembolism 50. In preferredembodiments, there is no need (as in prior art devices) to have thelumen move relative to the grasping jaws/nets so as to constrict the jaw11 elements around a foreign object, as the operation of the trigger 41on the handle 40 acts to pull the cord extending through the hollowcorrugated structure 30, and causes the jaws/nets 11, 15, 16 toencompass or otherwise grasp the foreign object 50 without the need tohave such jaws/nets 11, 15, 16 be in sliding/collapsible contact with acatheter lumen to achieve opening and closing of the gripping elements.It is believed that the present invention, in comparison with prior artdevices, therefore provides for a grasping procedure that is less proneto having grasping elements get stuck at a lumens/interface, and thatthe present invention provides a much more dependable and efficientmanner by which foreign objects can be accessed and grasped, with thephysician controlling the movement of the jaws/nets 11, 15, 16 withouthaving to worry about the lumen/grasping element frictional movementsinvolved with numerous prior art devices. In other words, unlike priorart systems, such as described by Tran in U.S. Pat. No. 6,679,893, byemploying the present invention there is no need to advance a deliverycatheter distally to press against proximal arm sections so as to forcedistal arm sections to rotate radially inwardly to a partiallycontracted configuration so that object engaging members may engage anobject, such as a thromboembolism. Instead, using the present invention,a surgeon is able to operate the trigger hand-held handle to achievegrasping and control of an object.

In yet further embodiments of the present invention, various otherfeatures may be included, such as the employment of magnets, cuttingelements, ligating elements, etc. Detailed support for how such featurescan be implemented will be clear to one of skill in the art as guided bythe present application, as well as the patent references incorporatedherein. For example, magnets may be positioned on the distal end of thedevice, and the jaws/nets may be supplanted with or added to sharpcutting implements 52 to one or both of the jaws such that a severingoperation can be performed. The sharpened cutting jaws 52 canalternatively be operated by a separate handle trigger—or simplyprovided in a fashion such that the cutting blade can be reversiblyretracted by a user (either remotely via a handle trigger operation—ormanually, prior to the extension of the device.) Similarly, suction cupscan be positioned and affixed to the distal end of the device, whetheron the jaws themselves or associated surfaces of the distal end, suchthat additional securement of remote objects is facilitated. Given theflexible nature of the device, it is possible to twist two separateextensions around each other, thus forming a single extension thatcomprises a twisted (helical) portion of a device, which can have twoseparate triggers to operate the pulling of cords extending in theseparate extended, twisted portions. This facilitates further optionsfor a user in certain situations where an additional set of operabledistal features, such as a separate set of jaws, may be useful. Alighting source can also be positioned at the distal end of the deviceso that a user can more readily see the distal end and facilitate properpositioning of the distal end to perform operations, such as clamping ofjaws around a distant object that may be in a darkened environment. LEDlighting sources with small, battery powered energy sources arepreferred, but one of skill in the art will appreciate, given theguidance provided herein, the vast variety of other lightingarrangements and features that can be employed while still being withinthe scope of the claimed invention. A magnifying viewing device (e.g., adistally positioned camera) can also be provided to assist the user inviewing the distal end of the device in particular applications, such aswhen a detailed and sensitive manipulation of a remote object isrequired and the user requires magnification of the distal end toproperly position the device to perform desired functions.

FIG. 5 shows an embodiment where opposing nets 15, 16 and cutting jaws52 are shown to facilitate reduction in the size of an object 50, suchas a blood clot, stone or foreign object, prior to or after grasping theobject within the opposing collapsible nets 15, 16. Thus, in certainembodiments, a physician can operate the trigger 41 on the handle 40 tocause the grasping assembly 10 to cause the jaws 11, net 15, 16 or othergrasping elements advance around a thromboembolism, foreign object orstone 50, and once secured in the grasp of the tool, the object 50 canthen be cut into pieces via one or more cutting operations via thereversible closure of the cutting blades 52, also operable via a cordextending through the corrugated central portion 30 and operablyconnected to a trigger 4 workable by the surgeon. In such a manner, theprior difficulties and problems experienced with attempting to grasp andpull or advance a foreign object (e.g. a stone, thrombus, etc.) througha delicate tissue lumen, e.g., due to the girth and size of suchobjects, is addressed by either cutting such object 50 prior to graspingthe same, or more preferably, by grasping the object 50, either via thejaws 11, spring-like fingers 11 or nets 15, 16 as disclosed herein, andthen closing the sharp cutting implements 52 associated with one or moreof the jaws 11, fingers 11 or nets 15, 16, such that a severingoperation can be performed. The pieces of the object 50 are thusentrapped in the jaws 11 or nets 15, 16 and can be safely removed fromthe lumen without the threat of damage to the lumen tissue upon removal.

Thus, various embodiments are directed to a selectively bendable remotegripping tool for entrapping an object located in an interior portion ofa person's anatomy to achieve its extraction therefrom, the toolcomprising a jaw portion 10 having a pair of net assemblies 15, 16movable relative to each other between fully clamped and fully openedpositions thereof; a handle portion 40 spaced apart from the jaw portion10 by a selectively extendible central portion, the handle portion 40comprising a first manually-actuatable trigger 41 operatively connectedto the jaw portion 10 by a selectively extendible pull member at leastsubstantially disposed within the central portion 70. Actuation of thetrigger 41 is operative to move the pull member to thereby selectivelyposition the pair of net assemblies 15, 16 between the fully clamped andfully opened positions. The central portion 70 preferably comprises atleast two separate portions that include hollow, corrugated members 30that have alternating ridges and grooves, with the central portion7—being bendable so as to position the tool into a desired bentconfiguration. A pull member comprising at least one cord operativelyconnects the handle portion 40 to the jaw portion 10, with the at leastone cord extending through the central portion. Miniature versions ofthe tool are adapted and configured for withdrawing thromboembolicmaterial and other foreign objects 50 from body lumens and cavities,employing a pair of jaws 11, nets 15, 16, or a combination thereof.Thus, in certain embodiments the invention is directed to a method andapparatus for managing polyps by which an elongated corrugated flexiblemember is positionable within a working channel of an endoscopic device,with a selectively bendable central column that at its distal end hasopposing nets 15, 16 that are movable between open and closed positionsvia a handle 40 having a trigger 41 that operates the nets 15, 16, thusallowing a physician to, for example, grasp an object 50, such asportion of a foreign body, a polyp, a clot, a stone, etc. in a fashionthat retains the object for removal with the corrugated flexible member30.

As shown in FIG. 6, other embodiments may include one or more otherfeatures, such as a suction cup, a lighting element 905, a magnifyingviewing device, and a camera may be affixed to a distal portion of thedevice, near to, for example, the gripping portion 10 of the device. Forexample, FIG. 6 shows a lighting element 905 in association with theengagement elements (jaws 11 a, 11 b). Also incorporated herein by thisreference is US patent publication no. 2013/0096457 to Qui, et al. withrespect to various embodiments of lighting elements that may beemployed.

While embodiments of the invention have been illustrated and described,it is not intended that these embodiments illustrate and describe allpossible forms of the invention. Rather, the words used in thisspecification are words of description rather than limitation, and it isunderstood that various changes may be made without departing from thespirit and scope of the invention. It is to be understood that theinvention is not limited to the precise configuration and componentsdisclosed herein. Various modifications, changes, and variations whichwill be apparent to those skilled in the art may be made in thearrangement, operation, and details of the methods and systems of thepresent invention disclosed herein without departing from the spirit andscope of the invention. It is important, therefore, that the claims beregarded as including any such equivalent construction insofar as theydo not depart from the spirit and scope of the present invention.

What is claimed is:
 1. A hand-held gripping device that allows a surgeonto reach interior portions of a person's anatomy, comprising: a grippingportion comprising a pair of nets movable between a fully clampedposition and a fully opened position; a handle portion spaced apart fromthe gripping portion by a central portion comprising a hollow,corrugated member having alternating ridges and grooves, the centralportion being deformable along its length for bending and orienting to anon-permanent position, wherein the handle portion comprises a firstmanually-actuatable trigger operatively connected to the grippingportion by a pull member at least substantially disposed within thecentral portion, whereby actuation of the trigger is operative to movethe pull member to thereby selectively position the gripping portionbetween the fully clamped position and the fully opened position; saidpull member comprising a one cord operatively connecting the handleportion to the gripping portion, said cord extending through saidcentral portion, the central portion comprising a plurality ofinterconnected connectors which together define a single passagewaythrough which said cord passes through; wherein each of the plurality ofinterconnected connectors is in engagement with another of saidinterconnected connectors, thereby permitting pivoting movement withrespect to said interconnected connectors; wherein the central portionremains bendable during the actuation of the trigger and the positioningof the gripping portion between the fully clamped position and the fullyopened position; and wherein a sharp cutting implement is associatedwith the gripping portion such that a severing operation can beperformed when the gripping portion is in the fully clamped position. 2.The device as set forth in claim 1, wherein said central portioncomprises a plurality of connector bodies that interconnect with eachother.
 3. The device as set forth in claim 1, wherein said deviceincludes a lamp or LED positioned near said gripping portion.
 4. Thedevice as set forth in claim 1, further comprising a locking memberassociated with said central portion to fix two adjacent members of saidcentral portion in an engaged position.
 5. The device as set forth inclaim 1, wherein said pull member is interconnected to the trigger, saidtrigger being operable by a surgeon's fingers.
 6. The device as setforth in claim 1, wherein one of a lighting element, a magnifyingviewing device, and a camera are affixed to the gripping portion of thedevice.
 7. The device as set forth in claim 1, wherein said grippingportion includes a magnet.
 8. A hand-held gripping device for a surgeonto reach interior portions of a person's anatomy, comprising: a grippingportion comprising a pair of nets movable between a fully clampedposition and a fully opened position; a handle portion spaced apart fromthe gripping portion by a central portion, the entire length of saidcentral portion consisting essentially of a hollow, corrugated memberhaving alternating ridges and grooves, wherein the handle portioncomprises a first manually-actuatable trigger operatively connected tothe gripping portion by a pull member at least substantially disposedwithin the central portion; whereby actuation of the trigger isoperative to move the pull member to thereby selectively position thegripping portion between the fully clamped position and the fully openedposition; said pull member consisting essentially of a cord operativelyconnecting the handle portion to the gripping portion, said cordextending through said central portion; and wherein said pull member isinterconnected to the trigger, being operable by a surgeon's fingers;wherein the central portion comprises a plurality of interconnectedconnectors which together define a passageway through which said pullmember passes through, said plurality of connector bodiesinterconnecting with each other and having a single aperturetherethrough through which said pull member passes through; wherein thecentral portion remains bendable during the actuation of the trigger andthe positioning of the gripping portion between the fully clampedposition and the fully opened position; and wherein at least one of asharp cutting implement, a lighting element, a magnifying viewingdevice, and a camera are affixed to the gripping portion of the device.9. The device as set forth in claim 8, wherein at least one sharpcutting implement is associated with the gripping portion such that asevering operation can be performed.
 10. The device as set forth inclaim 8, wherein said pair of nets comprise at least one taut net. 11.The device as set forth in claim 10, wherein said gripping portionfurther comprises opposing cutting jaws.
 12. A hand-held gripping devicethat allows a surgeon to reach interior portions of a person's anatomy,comprising: a gripping portion movable between a fully clamped positionand a fully opened position, said gripping portion comprising a pair ofnets; a handle portion spaced apart from the gripping portion by acentral portion, the central portion comprising a hollow, corrugatedmember having alternating ridges and grooves, the central portion beingdeformable along its length for bending and orienting to a non-permanentposition; wherein the handle portion comprises a firstmanually-actuatable trigger operatively connected to the grippingportion by a pull member at least substantially disposed within thecentral portion; whereby actuation of the trigger is operative to movethe pull member to thereby selectively position the gripping portionbetween the fully clamped position and the fully opened position; saidpull member comprising a cord operatively connecting the handle portionto the gripping portion, said cord extending through said centralportion; wherein the central portion comprises a plurality ofinterconnected connectors which together define a single passagewaythrough which said pull member passes through; wherein the centralportion remains bendable during the actuation of the trigger and thepositioning of the gripping portion between the fully clamped positionand the fully opened position; and wherein said gripping portion isreversibly dissociable to accommodate a user's selection of nets havingone of different types of designs, sizes, mesh patterns and geometries.13. The device as set forth in claim 12, wherein said gripping portionis in telescoping relationship with an adjacent portion of said centralportion.
 14. The device as set forth in claim 12, wherein at least oneof a sharp cutting implement, a lighting element and a camera areaffixed to the gripping portion of the device.
 15. The device as setforth in claim 12, wherein said pair of nets comprise at least one tautnet.
 16. The device as set forth in claim 12, wherein the plurality ofinterconnected connectors have no apertures other than the one throughwhich the cord passes through.
 17. The device as set forth in claim 8,wherein said gripping portion includes a magnet.
 18. The device as setforth in claim 12, wherein said gripping portion includes a magnet. 19.The device as set forth in claim 1, wherein said pair of nets compriseat least one taut net.
 20. The device as set forth in claim 12, whereinsaid pull member is interconnected to the trigger, said trigger beingoperable by a surgeon's fingers.